New Drugs at FDA: CDER’s New Molecular Entities of 2013
Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, FDA provides scientific and regulatory advice needed to bring new therapies to market. The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.
Each year, CDER approves a wide range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.
Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of theseproducts contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.
The list below includes the NMEs approved by CDER in calendar year 2013.
(The Drug Name link provides full product details, i.e., prescribing information, approval history, and reviews.)
What it’s used for
|11.||Xofigo||radium Ra 223 dichloride||5/15/13||To treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs.|
|10.||Breo Ellipta||fluticasone furoate and vilanterol inhalation powder||5/10/13||For the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.|
|9.||Invokana||canagliflozin||3/29/13||Used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.|
|8.||Tecfidera||dimethyl fumarate||3/27/13||To treat adults with relapsing forms of multiple sclerosis (MS).|
|7.||Dotarem||gadoterate meglumine||3/20/13||For use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.|
|6.||Lymphoseek||technetium Tc 99m tilmanocept||3/13/13||A radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.|
|5.||Osphena||ospemifene||2/26/13||To treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.|
|4.||Kadcyla||ado-trastuzumab emtansine||2/22/13||For patients with HER2-positive, late-stage (metastatic) breast cancer.|
|3.||Pomalyst||pomalidomide||2/8/13||To treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.|
|2.||Kynamro||mipomersen sodium||1/29/13||To treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). |
|1.||Nesina||alogliptin||1/25/13||To improve blood sugar control in adults with type 2 diabetes.|